Pharma and Healthcare Compliance Manager

Kuehne + Nagel ,
Birmingham, West Midlands
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Overview

Pharma and Healthcare Compliance Manager | United Kingdom | GB11563 We have an exciting new opportunity for a Compliance Manager specialising in Pharma and Healthcare. If you hold Responsible person status then we would be interested in talking to you. YOUR ROLE Your role is to ensure EU Directives and Medicines and Healthcare products Regulatory Authority (MHRA) guidelines on Good Distribution Practice (GDP) are implemented and complied with across our Business Units. YOUR RESPONSIBILITIES Ensure the quality management system (QMS) is documented, implemented and maintained and meets the requirements for GDP, ISO9001 and CEIV Pharma. To continuously improve our QMS and associated processes. Implement programs to ensure our customer requirements for quality and Good Distribution Practice (GDP) compliance are fully implemented and maintained. Focus on the management of authorised activities and the accuracy and quality of records. Approve the initial and continuous training programme for all personnel involved in distribution activities; deliver compliance training in accordance with company standards as required. Act promptly to manage and coordinate any medicinal product recall requirement. Liaise with operational staff to ensure customer complaints are dealt with effectively. Perform the qualification and approval of suppliers and customers. YOUR SKILLS AND EXPERIENCES Experience in a quality assurance function within the pharmaceutical industry or the pharmaceutical distribution industry and the associated supply chain needs; you will also have successfully completed an MHRA accredited Responsible Person course and will be or must have been previously named as an Responsible Person on a licence. An excellent working knowledge of the principals and guidelines of Good Distribution Practice (GDP) and the associated legislation as well as an understanding of the Falsified Medicines Directive, specifically the scanning and decommissioning requirements that are applicable within the supply chain. An understanding of the compliance requirements for the transport and storage of Controlled Substances and the associated Home Office Guidance; knowledge of government legislation around Pharma transportation is critical. Understanding of QSHE processes, requirements and formats and compliance to ISO9001 with excellent knowledge of GDP and a sound understanding of Good Manufacturing Practice. Experience in writing clear and concise policies and procedures. An ability to interpret complex guidance and legislative requirements and translate into simple instructions and documents is really important. Excellent verbal and written communication skills; with an ability to present well, able to negotiate and solve problems and work collaboratively with colleagues and our customers. Experienced auditor (preferably a lead auditor). Able to travel ( this role will involve travel to sites throughout the UK, mainly Sheffield, East Midlands and Heathrow, but will also include Manchester, Newcastle, Milton Keynes). GOOD REASON TO JOIN If you would like to become a valued member of our team then we will also make sure that you're rewarded for your commitment and expertise. We are offering a competitive salary with discretionary bonus, company car or car allowance and 25 days holiday plus bank holidays, life assurance and private health insurance. You will also have the opportunity to join the contributory KuehneNagel pension plan and benefit from our Route 2 Rewards scheme which offers discounts and savings on a wide range of high street or internet goods and services. ABOUT KUEHNE NAGEL With over 82,000 employees at some 1,300 locations in over 100 countries, the Kuehne Nagel Group is one of the world's leading logistics companies. As an employer, Kuehne Nagel stands for equal opportunity and we are committed to diversity in our teams with regard to people with disabilities. We believe that you can make a valuable contribution to Kuehne Nagel and look forward to receiving your application. CONTACT UK Resourcing Team This job was originally posted as www.totaljobs.com/job/89823995

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